Healthcare Services (Clinical Laboratory Service and Radiological Service) Regulations 2021
Table of Contents
Enacting Formula
Part 1 PRELIMINARY
1 Citation and commencement
2 Definitions
3 Application of Regulations
4 Specified services
4A Notification of certain imaging modalities
4B Prohibited service delivery modes
Part 2 REQUIREMENTS RELATING TO PERSONNEL
5 Skills and competencies of Clinical Governance Officer for clinical laboratory service
6 Skills and competencies of Clinical Governance Officer for radiological service
7 Additional duties and responsibilities of Clinical Governance Officer
8 Licensee must appoint section leader
9 Duties of section leader
10 General requirements relating to personnel
Part 3 PROCESSES, EQUIPMENT AND FITTINGS
11 Quality management system
12 Equipment and fittings
12A Additional requirements where applicable service provided using approved conveyances or at temporary premises
13 Services may be provided to patients only where ordered by requestor
Part 4 SAFETY REQUIREMENTS
14 Safety programme
15 Licensee must ensure personnel comply with safety plans
16 Personal protective equipment must be provided
Part 5 REQUIREMENTS SPECIFIC TO CLINICAL LABORATORY SERVICES
17 Instructions for collection of specimens
18 Acceptance and rejection of specimens
19 Handling and transport of specimens
20 Tests must have clinical utility
21 Tests must be accurate
22 Standards for reagents
23 Chemical hygiene plan and facilities
23A Tests on radioactive specimens
24 Documentation relating to tests
25 Quality control of tests
Part 6 REQUIREMENTS SPECIFIC TO RADIOLOGICAL SERVICES
26 Facilities and equipment
27 Required qualifications for conducting radiological examinations
28 Handling of radiological images
29 General safeguards for radiological examinations
30 Specific safeguards where radiological examination involves contrast agent
31 Specific safeguards where radiological examination involves anaesthesia or sedation
32 Testing of specimen
32A Conduct of simple in vitro diagnostic test
32B Instructions for self-collection of specimens
Part 7 REPORTING OF RESULTS
33 Who is qualified person in relation to reports
34 Written reports must be issued
35 Contents of reports
36 Urgent notification of results or findings in emergency
37 Identification and review of incidental or abnormal findings
38 Notification of error
39 Copies of reports must be complete
40 Processes to ensure prompt reporting
Part 8 MISCELLANEOUS
41 Outsourcing of tests or radiological examinations
42 Clinical laboratory service licensee — records to be kept for each specimen
43 Clinical laboratory service licensee — records to be kept for each test
44 Radiological service licensee — records to be kept in relation to each radiological examination
44A Tracing of records from report
45 Keeping of other records
46 Price transparency
47 Display of charges
48 Offence